Validation Engineer IV

Validation Engineer IV Canton, MA

Job Req code: 910

Category: Quality Systems

Organogenesis corporate headquarters is located in Canton, Massachusetts, including manufacturing, R&D, customer service, reimbursement and other corporate teams supporting our full range of products. We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing.

The VALIDATION ENGINEER IV (CMO Support and Projects) position, will be primarily designated to support validation activities at various OI contract manufacturing sites as assigned for support of new, existing, and transferred OI products.  In addition, this position will also support the establishment of OI requirements, validation activities, justifications and assessments for new projects as directed. 

The Validation Engineer IV will be responsible for Validation QA oversight in all validation current and pending processes at OI Contract Manufacturing Organizations (CMOs). This position will primarily provide ongoing direction and support for assessing the potential impact on established processes of any equipment, process and/or procedure changes, and determining the need for additional qualifications and/or other supporting documentation to maintain a GMP compliant validated state. Assessments will also involve the timely review and analysis of validation and qualification packages, or other support documentation generated by the CMO or by OI representatives for various equipment and processes. This position will require a strong understanding of manual processing in an aseptic environment and the supporting processes feeding that environment.  This position will primarily serve as a liaison between OI and OI CMOs and require routine participation in established and ad hoc meetings in support of ongoing production increase targets. 

Primary Job Responsibilities (CMO Support):

• Provides ongoing validation recommendations for requested changes or modifications to existing validated equipment and processes.
• Ensures all implemented processes and solutions are CGMP compliant.
• Reviews all OI product impact or related protocols and reports for new validations and revalidation work. These protocol types may include the following: studies for equipment including heat sealers, peristaltic pumps, autoclaves, glass washers, refrigerators, walk-in coolers, incubators, clean rooms, freezers, cleaning efficacy studies, smoke studies and thermal shipping studies
• Provides written justifications or assessments for changes as required.
• Creates documented assessments of previously approved CMO validations for GMP compliance, OI validation requirements, risk to OI products or product processing, storage and distribution.
• Reviews validation studies for microbiological testing.
• Reviews and assesses or assists in providing guidance in the generation of facility and process qualifications.
• Works with CMOs to adjusts equipment or processes that require improvement and/or repair
• Provide support and direction for manual and semi-automated cleaning validation as required.
• Participate in the creation and/or review of Standard Operating Procedures (SOPs) for equipment and processes in support of production.

Additional Job Responsibilities (Projects, as assigned)

• Prepares all protocols and reports for validation and revalidation work
• Coordinates and executes validation studies for equipment including autoclaves, glass washers, depyrogenation ovens, utility systems (purified water, WFI water, gas systems, clean steam), incubators, clean rooms, freezers, and cold rooms
• Performs testing using standard concepts, practices and procedures of the cGMP process
• Reviews and summarizes equipment history files to assess the validated state of equipment
• Performs a variety of validation tasks and projects outside classical validation tasks and apply diverse engineering development skills in a creative manner to increase operational efficiencies and product quality, and decrease costs as assigned by supervisor and/or designee
• Participate in the creation and/or review of Standard Operating Procedures (SOPs) for system projects

RequirementsThe candidate must have strong validation experience in the Pharmaceutical/Medical Device industry, be familiar with aseptic processing and clean room operations, be able to work independently, possess strong organizational skills, and have good written and verbal communication skills. This position will require a minimum of a Bachelor’s degree, with 5-7 years of experience in validation specific to the areas noted above.

Candidate will be a highly motivated and creative individual with strong validation principle understanding working under minimal supervision.  Strong technical writing skills are preferred. This position reports to the Associate Director of Validation.